The structured consensus method was a feasible and fair mechanism for choosing candidate tests, and direct comparison of beta battery tests in a common sample allowed selection of a final consensus battery. The MATRICS Consensus Cognitive Battery is expected to be the standard tool for assessing cognitive change in clinical trials of cognition-enhancing drugs for schizophrenia. It may also aid evaluation of cognitive remediation strategies.

No abstract

Co-norming a battery such as the MATRICS Consensus Cognitive Battery, comprising tests from independent test developers each with their own set of norms, facilitates valid interpretation of test scores and communication of findings across studies. These normative data will aid in estimating the magnitude of change during clinical trials of cognition-enhancing agents and make it possible to derive more directly interpretable composite scores.

The suggested guidelines represent reasonable starting points for trial design of cognitive-enhancing drugs, with the understanding that new data, subsequent findings, or other methodological considerations may lead to future modifications.

People with schizophrenia frequently have significant problems in community functioning. Progress in developing effective interventions to ameliorate these problems has been slowed by the absence of reliable and valid measures that are suitable for use in clinical trials. The National Institute of Mental Health convened a workgroup in September 2005 to examine this issue and make recommendations to the field that would foster research in this area. This article reports on issues raised at the meeting. Many instruments have been developed to assess community functioning, but overall insufficient attention has been paid to psychometric issues and many instruments are not suitable for use in clinical trials. Consumer self-report, informant report, ratings by clinicians and trained raters, and behavioral assessment all can provide useful and valid information in some circumstances and may be practical for use in clinical trials. However, insufficient attention has been paid to when and how different forms of assessment and sources of information are useful or how to understand inconsistencies. A major limiting factor in development of reliable and valid instruments is failure to develop a suitable model of functioning and its primary mediators and moderators. Several examples that can guide thinking are presented. Finally, the field is limited by the absence of an objective gold standard of community functioning. Hence, outcomes must be evaluated in part by ''clinical significance.'' This criterion is problematic because different observers and constituencies often have different opinions about what types of change are clinically important and how much change is significant.

Psychometric properties of all of the measures were considered acceptable, and the measures were generally comparable across the various criteria, except that the functional capacity measures had stronger relationships to cognitive performance and fewer missing data. The development and evaluation of potential co-primary measures is still at an early stage, and it was decided not to endorse a single measure for clinical trials at this point. The current findings offer the initial steps to identify functionally meaningful co-primary measures in this area and will help to guide further evaluation of such measures.

No abstract

This article presents an extended (7-9 hours) and a brief (1-2 hours) battery designed to evaluate early cognitive changes associated with seropositive, asymptomatic persons. The battery was recommended by an NIMH Workgroup which was guided by 10 principles in its development. The domains assessed by the battery are: (1) Indicators of Premorbid Intelligence; (2) Attention; (3) Speed of Processing; (4) Memory; (5) Abstraction; (6) Language; (7) Visuoperception; (8) Constructional Abilities; (9) Motor Abilities; and (10) Psychiatric Assessment. Although the battery assesses a wide range of psychological functioning, specific emphasis has been placed on divided and sustained attention as well as speed of processing and retrieval from working and long-term memory. Descriptions of both the traditional clinical tests and tasks used in cognitive psychology are provided. Although the Workgroup strongly recommends the use of the extended battery in order to ensure the most sensitivity, it recognizes that there may be situations in which this is not possible. In order to increase the likelihood that neuropsychological tests will identify neurologically affected CDC Stage II and III seropositive individuals, the Workshop recommends that each patient's protocol be rated by two trained neuropsychologists using the same clinical criteria. The Workgroup also recommends that a concerted effort be made to incorporate data from the extended and the brief batteries in some central data bank.